Cleared Traditional

K960674 - CONTRAST INJECTION LINES

K960674 is an FDA 510(k) clearance for CONTRAST INJECTION LINES, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K960674 · B.Braun Medical, Inc. · Cardiovascular device
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Sep 1996
Decision
212d
Days
Class 2
Risk

K960674 is an FDA 510(k) clearance for the CONTRAST INJECTION LINES. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on September 19, 1996 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K960674

510(k) Number K960674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date September 19, 1996
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 163
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K960674.
MEDRAD DISPOSABLE SYRINGES
K964642 · Medrad, Inc. · Apr 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · B.Braun Medical, Inc. · Mar 1997
RNS STERILE, DISPOSABLE CT BIOPSY TRAY
K955685 · Contour Fabricators of Florida, Inc. · Oct 1996
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
K960965 · Coeur Laboratories, Inc. · Sep 1996
CONTROL SYRINGE
K960430 · Scientific Device Manufacturer, LLC · Aug 1996
RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
K955684 · Contour Fabricators of Florida, Inc. · May 1996